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Lobbying Group Appeals Decision Allowing California Pay-for-Delay Law to Take Effect
The law made California the first state to bar pay-for-delay pharmaceutical agreements by making them presumptively anticompetitive if the nonreference drug maker receives anything of value from the other company.
The Association for Accessible Medicines (AAM), which represents generic drugmakers, is appealing a December 31 decision by a federal judge that allows California’s new law barring pay-for-delay arrangements between brand-name and generic pharma firms to go forward.
Last week, AAM filed a notice of appeal with the U.S. Court of Appeals for the Ninth Circuit.
The law, AB 824, made California the first state to bar pay-for-delay pharmaceutical agreements by making them presumptively anticompetitive if the nonreference drug maker receives anything of value from the other company. The bill would make violating these provisions punishable by civil penalty of up to $20 million per violation.
Increased competition from generics and biosimilars breaks up drug monopolies and lowers pharmaceutical costs, the state has said. California patients and state programs saved $26 billion in 2018 alone by using generic prescription drugs.
AAM had argued that the law violated the federal government’s right to regulate interstate commerce and the scope of US patents. The judge hearing the case for the Eastern District of California refused to enter a preliminary injunction against the law going into effect, saying AAM had not met its burden of proof for a preliminary injunction.
In 2013, the Supreme Court ruled in FTC v Actavis that a brand-name drug maker’s payment to a generic competitor to settle patent litigation can violate antitrust laws if the plaintiffs demonstrate that the defendants are engaged in anticompetitive behavior on a case-by-case basis by imposing an unreasonable restraint of trade based on economic factors.
Senators Introduce Bipartisan Legislation to Protect Skinny Labeling
January 2nd 2025To close out the year, 4 senators came together to introduce a new bipartisan bill to protect biosimilar and generic drug manufacturers from patent litigation when obtaining “skinny label” approvals for their products.
Biosimilars Policy Roundup for September 2024—Podcast Edition
October 6th 2024On this episode of Not So Different, we discuss the FDA's approval of a new biosimilar for treating retinal conditions, which took place in September 2024 alongside other major industry developments, including ongoing legal disputes and broader trends in market dynamics and regulatory challenges.
How Vertical Integration Drives Innovation and Access in Biosimilars
December 27th 2024Elie Bahou, PharmD, highlights how vertical integration in the biosimilar industry streamlines costs, improves supply reliability, accelerates market adoption, and enhances patient access, while emphasizing the value of collaboration, quality control, and value-based contracts for sustainable health care delivery.
Empowering Vulnerable Populations: The Path to Equitable Biologic Therapy Access
December 22nd 2024Elie Bahou, PharmD, senior vice president and system chief pharmacy officer at Providence, discusses strategies to improve equitable access to biologic therapies, including tiered formularies, income-based cost sharing, patient assistance programs, and fostering payer partnerships.
13 Strategies to Avoid the Nocebo Effect During Biosimilar Switching
December 18th 2024A systematic review identified 13 strategies, including patient and provider education, empathetic communication, and shared decision-making, to mitigate the nocebo effect in biosimilar switching, emphasizing the need for a multifaceted approach to improve patient perceptions and therapeutic outcomes.
